Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL

Exclusion Criteria

• •1. Past receipt of a total of ≥ 300 mg/m\^2 doxorubicin equivalents (600 mg/m\^2 daunorubicin, 60 mg/m\^2 idarubicin, 75 mg/m\^2 mitoxantrone)
• •2. Current or past history of pancreatitis
• •3. QT interval on electrocardiogram (ECG) \> 0.45 by Framingham formula
• •4. Known congestive heart failure
• •6. Presence of central nervous system (CNS) disease
• •7. Pregnancy or lactation
• •8. Chronic liver disease including chronic active hepatitis and/or cirrhosis
• •9. Active Hepatitis B virus (HBV) by core antibody, surface antigen (HBsAg) or viral load
• •10. Active Hepatitis C virus (HCV) (positive antibody test confirmed by viral load if antibody test is positive)
• •11. Known history of infection with Human Immunodeficiency Virus (HIV)
• •12. Active or uncontrolled infections
• •13. Abnormal baseline hepatic ultrasound (including Dopplers)
• •14. Prior allogeneic stem cell transplant
• •15. Prior use of inotuzumab ozogamicin
• •16. Known diagnosis of hemochromatosis with iron overload
• •17. Treatment with steroids or hydroxyurea for more than 7 days with each within the 2 weeks prior to registration -that is, each is allowed for up to 7 days
• •18. Gastrointestinal tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease, or inability to swallow medications.
• •19. Philadelphia chromosome positive B-cell ALL